Silicone implants approved for U.S.
The Food and Drug Administration (FDA) has approved the use of silicone breast implants. This decision comes 14 years after the FDA restricted access to the silicone implants because of safety concerns.
The FDA decision followed a lengthy process in which the agency sent "approvable with conditions" letters to the two silicone breast implant manufacturers in the second half of 2005. The approvable letter stipulated conditions that the manufacturers needed to satisfy to receive FDA final approval to market and sell silicone breast implants. These letters came after an FDA advisory panel hearing in April 2005 in which the panel heard more than 20 hours of data presentations from the manufacturers and public comment.
Approximately 300,000 women chose breast augmentation in 2005, according to statistics from the American Society of Plastic Surgeons (ASPS) and from the American Society of Aesthetic Plastic Surgeons. Nearly 58,000 women had breast reconstruction in 2005, according to ASPS.
The Food and Drug Administration (FDA) has approved the use of silicone breast implants. This decision comes 14 years after the FDA restricted access to the silicone implants because of safety concerns.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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